| Primary Device ID | 00860001700169 |
| NIH Device Record Key | bd52daa9-d7c7-4d34-a2e0-75892f0a4544 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stitching Platform with Handles/ Clear Stitching Stand |
| Version Model Number | CSS[X]; SPH-F |
| Company DUNS | 102370137 |
| Company Name | Reina Imaging |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 00860001700107 - Collim-Aid | 2023-06-16 The Collim-Aid fits onto the collimator, shielding the patient, the operator, or other persons from unnecessary exposure to rad |
| 00860001700169 - Stitching Platform with Handles/ Clear Stitching Stand | 2023-06-16Designed as a patient stabilizer for use when taking a radiograph requiring stitching software. The device provides a stepping platform for the patient and a clear polycarbonate back that allows a radiology technologist to position the device centered to the image receptor, facilitating patient positioning. |
| 00860001700169 - Stitching Platform with Handles/ Clear Stitching Stand | 2023-06-16 Designed as a patient stabilizer for use when taking a radiograph requiring stitching software. The device provides a stepping p |
| 00860001700176 - Weight Bearing DRP Holders | 2023-06-16 Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor |
| 00860001700121 - Trans-Former | 2019-11-06 Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. I |
| 00860001700183 - Protect-A-Grid | 2019-11-06 The "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells.
They may als |